Medication assurance system and method

ABSTRACT

A medication assurance system for verification of both the medication and the patient is disclosed. A portable spectrometer is used to obtain a light spectrum of the medication. A subject identification or biometric device is used to identify the patient. A controller coupled to the portable spectrometer and the subject identification device identifies the medication by performing a chemometric analysis of the light spectrum. Based on the medication identified and the patient identified, the controller can determine if the medication is to be taken by the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present invention claims priority from U.S. Patent Application No.61/824,925 filed May 17, 2013 which is incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to medical equipment and methods, and inparticular to equipment and methods for drug verification and medicationassurance.

BACKGROUND OF THE INVENTION

Non-adherence to medication schedules causes $300 billion annual cost tohealthcare system in the US, including 10% of hospital admissions and23% of nursing home admissions. Globally, non-adherence claims millionsof lives and poses threat of untreatable diseases (Vermeire, E.,Hearnshaw, H., Van Royen, P., & Denekens, J. (2001). Patient adherenceto treatment: three decades of research. A comprehensive review. Journalof Clinical Pharmacy and Therapeutics, 26(5), 331-342). For diabetes,for every $1 spent on medication, $7 is saved on other medical costssuch as hospitalization. For high cholesterol, for every $1 spent, $5.10is saved. For hypertension, for every $1 spent, $3.98 is saved (MedcoHealth Solutions, 2005).

Another example is tuberculosis, which results in 1.9 million lethaloutcomes each year. Tuberculosis is normally curable with antibioticmedication administered over a period of 6 months. Adherence totuberculosis medication saves lives and prevents spread ofdrug-resistant tuberculosis strains. However, ensuring medical adherencecan be difficult in developing countries, especially in remote areas.Lack of adherence can result in death and development of drug-resistantforms of tuberculosis, which can infect other people and impedecontainment of the disease.

From the medication adherence perspective, three conditions must beensured: 1) an appropriate medicine must be administered 2) at anappropriate time or time intervals 3) to a right person or persons. Themedication assurance systems of the prior art can be broken down intothree general categories: A) electronic pillboxes; B) software-basedproducts; and 3) pill identification systems. The latter systems aremostly used for a specific task of drug identification for dispensingand marking.

Electronic pillboxes, or “smart” pillboxes, address the conditions 1)and 2) above, that is, taking the right medicine at the right time. Byway of example, MedFolio™ pillbox, distributed online atwwwmedfoliopillbox.com, is an electronic pillbox serving as a medicationidentifier and reminder system. MedFolio pillbox connects to a personalcomputer. A software program running on the personal computer allows thepatient or the caregiver to easily customize the device to specificmedication regimens. MedFolio pillbox has a series of medicationreminders, such as audio alerts and visual lighting alerts. The softwareprogram can communicate with a secure website to offer the option ofreceiving electronic messaging reminders.

Another example is MedReady™ cartwheel pillbox pre-loadable with pills,manufactured and distributed by MedReady, Inc., of Burlingame, Calif.,USA. The MedReady cartwheel pillbox sounds an alarm, prompting the userto take pills at regular time intervals. A battery back-up is providedfor preventing medication interruptions caused by power outages.

Yet another example of an electronic pillbox is MedSignals™ pillbox,manufactured by MedSignals, San Antonio, Tex., USA. The MedSignalspillbox reminds the patient, via alarms and a textual display, when andhow to take the medications, monitors the time of administering themedications, and communicates the collected information to remote caremanagers. Furthermore, yet another example is a Medminder™ electronicpillbox, manufactured by MedMinder Inc., Needham, Mass., USA. Once setup, the Medminer pillbox provides patient reminders and remotemedication adherence capabilities. The Medminder pillbox reminds thepatient to take a medicine by lighting up an appropriate compartment. Ifa cup of the compartment is not lifted within an assigned time, thepatient gets auditory prompts, as well as optional phone calls, textmessages, and emails. A remotely located caregiver can assess themedication adherence information via the Internet.

An example of a software-based medication assurance system is a PillJogger™ smartphone app, developed by Pill Jogger Inc., San Francisco,Calif., USA. The Pill Jogger app reminds patients to take their pills,and keeps track of the pills taken.

A “medical substance recognition system” is disclosed by Peter Botten inUS Patent Application Publication 2013/0221082 A1. The system controlspill dispensing to prevent dispensing errors. The system includes a“recognition device” based on a machine-vision digital camera, whichrecognizes various pills by their visual appearance. Botten also teachesthat the pill recognition device can utilize “the physical, chemical,luminescent and possibly other features” of the pills.

Wade M. Poteet et al. in U.S. Pat. No. 7,154,102 B2 disclose a systemand methods for detection and identification of chemical substancesusing UV fluorescence spectroscopy. Pharmaceuticals can be detected andidentified from wavelengths of UV fluorescence spectral peaks, andconcentrations of the pharmaceuticals can be evaluated from the strengthof the UV fluorescence signal.

Prasant Potuluri et al. in US Patent Application Publication2010/0045978 A1 disclose a system using a “spectral signature” of amedication for verification and identification purposes. The dataprocessing includes correction for “response function of thespectrometer”, intensity normalization, fluorescence removal, extractingthe spectral signature, and comparing the spectral signature to adatabase of spectral signatures of known pharmaceuticals.

Richard Garfein from University of San Diego, La Jolla, Calif., USA, hassuggested to provide via Internet cell phone video recordings ofpatients taking tuberculosis medicine at their homes, as a proof ofadherence to antibiotic treatment. This method has been termed“VCP-DOT”, or Video Cell Phone Directly Observed Therapy. However,VCP-DOT does not allow a medical professional to verify that a correctantibiotic medication was taken by the patient.

The prior art lacks a medication assurance system that would verify boththe medication to be taken and the patient identity, reducing chances ofincorrect medication, while providing an objective evidence of the factof taking an appropriate medication by an appropriate person atappropriate time.

SUMMARY OF THE INVENTION

A medication assurance system of the invention includes means forobjective verification of both the medication and the patient.Preferably, a handheld near-infrared (NIR) spectrometer based on alaterally variable filter (LVF) is used to identify the medication, anda biometric device, such as a fingerprint scanner, is used to identifythe patient. Both identifications can be performed as a matter ofseconds, providing quick, simple, and convenient medication verificationand assurance.

In accordance with the invention, there is provided a medicationassurance system comprising:

a portable spectrometer for obtaining a light spectrum of a medication;

a subject identification device for identifying a subject of medication;and

a controller coupled to the portable spectrometer and the subjectidentification device, configured for identifying the medication fromthe light spectrum obtained by the portable spectrometer using achemometric analysis; and determining if the medication is to be takenby the subject.

In accordance with the invention, there is further provided a medicationassurance system comprising:

a portable spectrometer for obtaining a light spectrum of a medication;

a subject identification device for identifying a subject of medication;and

a controller coupled to the portable spectrometer and the subjectidentification device, configured for identifying the medication fromthe light spectrum obtained by the portable spectrometer using achemometric analysis, and providing a record of administering theidentified medication to the identified subject, or person.

In a preferred embodiment, the portable spectrometer includes a lightsource for illuminating the medication, a medication holder for holdingthe medication being illuminated, a laterally variable optical filter(LVF) for receiving light reflected from, or transmitted through themedication, and a photodetector array optically coupled to the LVF forwavelength-selective detection of the reflected or transmitted light,respectively.

In accordance with the invention, there is further provided a method forpreventing a subject from taking an incorrect medication, the methodcomprising:

(a) using a portable spectrometer to obtain a light spectrum of amedication;

(b) identifying the medication by performing a chemometric analysis ofthe light spectrum obtained in step (a);

(c) identifying the subject using a biometric device;

(d) for the subject identified in step (c), determining an associatedmedication based on a pre-existing record;

(e) determining that the medication identified in step (b) is not theassociated medication determined in step (d); and

(f) upon completion of step (e), generating an alarm for informing thesubject that the medication is an incorrect medication.

In accordance with another aspect of the invention, there is furtherprovided a method for tracking administering of a mediation to asubject, the method comprising:

(a) using a portable spectrometer to obtain a light spectrum of amedication;

(b) identifying the medication by performing a chemometric analysis ofthe light spectrum obtained in step (a);

(c) identifying the subject using a biometric device;

(d1) creating a record including: a timestamp; the medication identifiedin step (b); and the subject identified in step (c).

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments will now be described in conjunction with thedrawings, in which:

FIG. 1 is a block diagram of a medication assurance system of theinvention;

FIG. 2 is a schematic view of a memory unit of the system of FIG. 1;

FIGS. 3A, 3B, and 3C are side cross-sectional views of a compactspectrometer configured for operation in diffuse reflection,transmission, and transflection, respectively, for use in the medicationassurance system of FIG. 1;

FIG. 4A is a side cross-sectional view of an LVF usable in thespectrometers of FIGS. 3A and 3B;

FIG. 4B is a transmission spectrum of the LVF of FIG. 4A at differentlocations on the LVF;

FIG. 5 is a schematic view of a pill dispenser of the invention;

FIG. 6 is a flow chart of a method of the invention for preventing asubject from taking an incorrect medication;

FIG. 7 is a flow chart of a method of the invention for trackingadministering of a mediation to a subject;

FIG. 8 is a two-dimensional Principle Component Analysis (PCA) scoresplot for Sildenafil™ drug of different strengths and Kamagra™, Zenegra™,and Sildigra™ XL illegal generic substitutions;

FIG. 9 is a two-dimensional PCA scores plot for Sildenafil, Kamagra,Zenegra, and Sildigra XL tablets, showing a 95% equal frequency ellipsefor Sildenafil;

FIG. 10 is a two-dimensional PCA scores plot for twenty three variousdrugs tested by the reflective compact spectrometer of FIG. 3A; and

FIG. 11 is a three-dimensional PCA scores plot for the drugs shown inFIG. 10.

DETAILED DESCRIPTION OF THE INVENTION

While the present teachings are described in conjunction with variousembodiments and examples, it is not intended that the present teachingsbe limited to such embodiments. On the contrary, the present teachingsencompass various alternatives and equivalents, as will be appreciatedby those of skill in the art.

Referring to FIG. 1, a medication assurance system 10 of the inventionincludes a portable near infrared (NIR) reflection spectrometer 12 forobtaining a diffuse reflection spectrum 12A of a pill 11. A fingerprintreader 14 is used for identifying a patient, not shown. A controller 16is coupled to the portable NIR reflection spectrometer 12 and thefingerprint reader 14. The controller 16 is configured for identifyingthe pill 11 by performing a chemometric analysis of the diffusereflection spectrum 12A obtained by the portable spectrometer 12, andfor identifying the patient based on a fingerprint image provided by thefingerprint reader 14. The controller 16 is configured for determiningif the identified pill 11 is to be taken by the identified patient, andcan also be configured for providing a record of administering theidentified pill 11 to the identified patient.

In the embodiment shown, the medication assurance system 10 includes aclock 18 coupled to the controller 16. A storage device 20 can becoupled to the controller 16 for storing a record comprising anidentifier of the patient; an identifier of the pill 11; and a timestampincluding the time of administering the pill 11 to the patient. Whilethe scheduled pill 11 administering time can be stored in thecontroller's 16 memory, the actual time the pill 11 was taken can beprovided by the clock 18. The stored records can be used to verify thatthe pill 11 has indeed been administered to the patient, thusestablishing a medication record. When the medication assurance system10 is used for clinical trials of a new drug, accumulated medicationrecords allow the clinical trial personnel to verify adherence to themedication schedule, thus substantiating the clinical trial findingsabout efficacy of the new drug.

The storage device 20 can be optionally disposed at a remote location22, and the medication assurance system 10 can include a wirelesstransmitter 24 for transmitting the medication record to the remotelocation 22 for storage on the remote storage device 20. This allows oneto centralize storage of multiple record from multiple medicationassurance systems 10, e.g. disposed at patient's homes or caregiver'slocations, at the single remote location 22.

Referring to FIG. 2 with further reference to FIG. 1, the controller 16can include a non-transitional memory 26 for storing a time schedule ofadministering of the medication to the patient, or in other words amedication schedule 28. The non-transitional memory 26 can also storepatient/medication information 29 in form of patient ID e.g. patientname, admission number, and fingerprint samples, and medicationsassociated with the patient as identified by the fingerprint samples. Inthis embodiment, the medication assurance system 10 of FIG. 1 includesan alarm device 19 e.g. an audible or a visual alarm, coupled to thecontroller 16. The alarm device 19 can provide an audible or visiblewarning signal when the patient identified using the fingerprint reader14 is going to take the pill 11 identified by the controller 16 to bedifferent from the associated medication. In addition, the controller 16can be configured to cause the alarm device 19 to provide an audible orvisible reminder of one of the times for the patient to take theassociated medication.

The alarm, clock, remote storage, and other functions can beconveniently implemented using computational and communicationcapabilities of smartphones. In a smartphone implementation, all of thefunctions of the controller 16 can be performed by the smartphone'smicroprocessor. The smartphone can be connected to the portable NIRreflection spectrometer 12 via a link 13 (FIG. 1), for example a USBcable, or a standardized wireless link such as Bluetooth™. The functionof the transmitter 24 would be performed by the smartphone's wirelessdata carrying capability. Furthermore, many smartphones nowadays includea global positioning system (GPS). Thus, the medication record providedby a smartphone-enabled medication assurance system can include not onlytime, but also a GPS location where the known or verified medication hasbeen administered to a known or verified subject, or person.

The fingerprint reader 14 can be replaced with another biometric devicesuch as an eye iris scanner, or more generally another subjectidentification device, for example a digital camera equipped with facialrecognition software. The portable NIR reflection spectrometer 12 can bereplaced with a portable reflection, transmission, or transflectionspectrometer operating in infrared, visible, or ultraviolet parts of thelight spectrum. Transmission spectrometers can be used for transparentmedications e.g. liquid medicines or mixtures. Transflectionspectrometer geometries can be used for translucent samples or powders.In a transflection measurement, the collected light includes reflectedlight, as well as light transmitted through the sample and reflected topropagate again through the sample. The collected light can includelight diffusely reflected from both the top and the bottom surfaces ofthe sample. A transflection spectrum measurement configuration will beconsidered further below, after reflective and transmissiveconfigurations.

Turning now to FIG. 3A with further reference to FIG. 1, a preferredembodiment 30A (FIG. 3A) of the portable NIR reflection spectrometer 12(FIG. 1) is shown. The portable NIR reflection spectrometer 30A of FIG.3A includes a light source 32 for illuminating a medication 31A e.g. thepill 11, and a medication holder 34 for holding the medication 31A beingilluminated by the light source 32. The light source 32 is configuredfor directing light 33 at the medication holder 34 at an acute angle asshown. An LVF 36 receives light 35A diffusely reflected from themedication 31A. A photodetector array 38 is optically coupled to the LVF36 for wavelength-selective detection of the diffusely reflected light35A. An on-board microcontroller 37 controls the operation of the lightsource 32 and processes the data from the photodetector array 38, thusobtaining the spectrum 12A of the diffusely reflected light 35A.

The portable NIR reflection spectrometer 30A preferably includes a lightcollecting element 39 disposed between the medication holder 34 and theLVF 36, for collecting the diffusely reflected light 35A from themedication 31A when the medication 31A is placed into the medicationholder 34 and illuminated by the light source 32, and coupling thediffusely reflected light 35A to the LVF 36. In the embodiment shown,the light collecting element 39 is a tapered light pipe having anarrower end 48 for receiving the diffusely reflected light 35A, and abroader end 49 near the LVF 36 for mixing and spreading the receiveddiffusely reflected light 35A, with an optional lens element on thebroader end 49 facing the LVF 36. Furthermore, in the preferredembodiment shown in FIG. 3A, the light source 32 includes first andsecond incandescent light bulbs 32A disposed symmetrically on both sidesof the light collecting element 39 for symmetrically illuminating themedication 31A placed in the medication holder 34. Advantageously, thefirst and second incandescent light bulbs 32A provide a smooth and wideinfrared spectrum of the illuminating light 33. A more detaileddescription of the portable NIR reflection spectrometer 30A is providedin a co-pending U.S. patent application Ser. No. 14/079,280, which isincorporated herein by reference.

Referring to FIG. 3B with further reference to FIGS. 1 and 3A, atransmission portable spectrometer 30B (FIG. 3B) can be used in place ofthe portable NIR reflection spectrometer 12 (FIG. 1). The portable NIRtransmission spectrometer 30B of FIG. 3B is similar to the portable NIRreflection spectrometer 30A of FIG. 3A, only a single light source, thatis, an incandescent lamp 32B, is placed under the sample holder 34holding a transparent e.g. liquid medication 31B. In other words, theliquid medication 31B is placed between the light source, that is, theincandescent lamp 32B, and the LVF 36. The incandescent lamp 32Bprovides a beam of light 35B, which propagates through the liquidmedication 31B. The on-board microcontroller 37 controls the operationof the incandescent lamp 32B and processes the data from thephotodetector array 38 to obtain a transmission spectrum 12B of theliquid medication 31B. Preferably, the portable spectrometers 30A and30B of FIGS. 3A and 3B, respectively, operate in the near-infrared (NIR)spectral range of 800 nm to 2500 nm, where inexpensive photodetectorarrays can be used.

Turning to FIG. 3C with further reference to FIGS. 1, 3A, and 3B, atransflection portable spectrometer 30C (FIG. 3C) can be used in placeof the portable NIR reflection spectrometer 12 (FIG. 1). The portableNIR transflection spectrometer 30C of FIG. 3C is similar to the portableNIR reflection spectrometer 30A of FIG. 3A. In the portable NIRtransflection spectrometer 30C of FIG. 3C, the medication holder 34 iscoated with a reflective coating 34C. In operation, the illuminatinglight 33 is not only reflected from the medication 31A, but is alsotransmitted through the medication 31A, reflected from the reflectivecoating 34C, is transmitted again through the medication 31A in anopposite direction, and is collected by the light collecting element 39.The light reflected from the reflective coating 34C can be reflected bya lower side of the medication 31A, reflected again by the reflectivecoating 34C, and is transmitted through the medication 31A forcollection by the light collecting element 39. In other words, thepresence of the reflective coating 34C allows one to obtain acombination of diffuse reflection and transmission spectrum, hereintermed “transflection spectrum” 12C of the medication 31A. Thetransflection measurement may be beneficial for translucent or powderedmedications 31A.

Turning to FIGS. 4A and 4B, the operation of the LVF 36 of the portablespectrometers 30A and 30B of FIGS. 3A and 3B, respectively, isconsidered in more detail. In FIG. 4A, the LVF 36 is flipped upside downas compared to FIGS. 3A and 3B, so that the reflected light 35Apropagates downwards, not upwards as in FIGS. 3A and 3B. The LVF 36 ofFIG. 4A includes a wedged spacer 42 sandwiched between wedged dichroicmirrors 43, to form a Fabry-Perot cavity with a laterally variablespacing between the dichroic mirrors 43. The wedge shape of the LVF 36makes its transmission wavelength laterally variable, as shown witharrows 44A, 44B, and 44C pointing to individual transmission peaks 45A,45B, and 45C, respectively, of a transmission spectrum 45 (FIG. 4B)shown under the LVF 36. In operation, the diffusely reflected light 35Aimpinges on the LVF 36, which separates the diffusely reflected light35A into the individual spectral components shown with the arrows 44A to44C.

Referring now to FIG. 5, the portable diffuse NIR reflectionspectrometer 30A can be coupled to an automatic medication dispenser 50for automatically dispensing the medication 31A the times of requiredadministering of the medication 31A to the subject. In the embodimentshown, the automatic medication dispenser 50 includes a cartwheel 52loaded with the pills 11 and rotatable as shown by an arrow 54. Themedication dispenser 50 can be mechanically coupled to the medicationholder 34 to place the medication 31A on the medication holder forspectral authentication as explained above. Of course, the automaticmedication dispenser 50 can also be used with the spectrometer 12 ofFIG. 1, as well as with other spectrometer types, such as the portableNIR transmission spectrometer 30B of FIG. 3B.

Still referring to FIG. 5, the embodiment of the medication assurancesystem 10 having the automatic medication dispenser 50 is particularlybeneficial in clinical trials, in which some of the subjects are givennew drugs being tested and some are given empty tablets called placebos.The automatic medication dispenser 50 of the medication assurance system10 can be programmed so that the medical personnel servicing a clinicaltrial is unaware of who of the participating human subjects is given thenew drug and who is given the placebos, thus enhancing reliability andfidelity of the trial.

Turning to FIG. 6 with further reference to FIGS. 1, 3A, and FIG. 3B, amethod 60 for preventing a subject from taking an incorrect medicationcan be practiced using the medication assurance system 10 of FIG. 1. Themethod 60 of FIG. 6 includes a step 61 of using a portable spectrometer,such as the diffuse reflection spectrometer 12 of FIG. 1, the diffusereflection spectrometer 30A of FIG. 3A, or a transmission spectrometer30B of FIG. 3B, to obtain a light spectrum of a medication. The lightspectrum can include the diffuse reflection spectrum 12A (FIG. 3A), thetransmission spectrum 12B (FIG. 3B), or a transflection spectrum 12C(FIG. 3C). In a step 62, the medication (the pill 11 of FIG. 1, themedication 31A of FIG. 3A, or the transparent medication 31B of FIG. 3B)is identified by performing a chemometric analysis of the light spectrumobtained in the previous step 61. The chemometric analysis can includePrincipal Component Analysis (PCA) followed by Soft Independent Modelingof Class Analogy (SIMCA). The chemometric analysis can also includeSupport Vector Classification (SVC) or Support Vector Regression (SVR);Linear Discriminant Analysis (LDA) or Quadratic Discriminant Analysis(QDA); TreeBagger Analysis or Random Forest Analysis; Partial LeastSquare Discriminant Analysis (PLS-DA); and other data regression andmultivariate analysis methods known to the skilled person.

In a step 63, the subject is identified using an identification orbiometric device, such as the fingerprint scanner 14. In a step 64, thecontroller 16 of the medical assurance system 10 consults a pre-existingrecord e.g. a table including the subject, or patient, identified in theprevious step 63, to determine a medication the identified subjectshould take, that is, the medication associated with the identifiedsubject. In a step 65, the medication identified in the second step 62is compared with the associated medication. If it is not the associatedmedication, then in a step 66, an audio and/or visual alarm is generatedfor informing the subject that the medication 11, 31A, or 31B, as thecase may be, is an incorrect medication and should not be taken by thesubject (patient). Furthermore, a blocking mechanism can be provided tophysically prevent the subject from taking the “wrong” medication. Theblocking mechanism, not shown, can be coupled to the controller 16 ofFIG. 1, to enable the controller to physically block the medication 11once the incorrect medication has been identified as such. The blockingmechanism can be integrated into the medication holder 34 of FIGS. 3A to3C.

Referring now to FIG. 7 with further reference to FIG. 1, the firstthree steps 61 to 63 of a method 70 for tracking administering of amediation to a subject are the same as the first three steps 61 to 63 ofthe method 60 of FIG. 6. The method 70 of FIG. 7 further includes afourth step 74 of creating a record including: a timestamp; themedication identified in the chemometric analysis step 62; and thesubject identified the subject identification analysis step 63. Therecord created in the step 74 can form a part of medication history of apatient, or form a part of an objective experimental base of a clinicaltrial.

In preferred embodiments of the methods 60 and 70 of FIGS. 6 and 7,respectively, the portable diffuse reflection spectrometer 31A of FIG.3A is used in the measurement steps 61, to obtain the diffuse reflectionspectrum 12A. Utilization of the laterally variable filter 36 opticallycoupled to the photodetector array 38 results in a very compactspectrometer weighting less than 100 g. Due to effective lightutilization and the ability to measure absorption at all wavelengthsimultaneously (i.e. no scanning, no single wavelength measurement) bythe spectrometer 31A, the data collection time can be very small, e.g.less than 1 second.

The performance of the portable diffuse reflection spectrometer 31A ofFIG. 3A in drug identification has been verified experimentally. Testshave been performed to determine a degree of certainty with whichdifferent medications can be identified and distinguished from eachother. The tests described below differentiate between “generic” and“illegal” versions of similar drugs, establishing a proof that NIRdiffuse reflection spectroscopy can indeed be used to identify drugs.

A MicroNIR™ diffuse reflection miniature spectrometer manufactured byJDS Uniphase Corporation, Milpitas, Calif., USA, was used to collect thespectral data. The MicroNIR spectrometer weights only 60 g and measures45 mm×42 mm. Prior to the samples analysis, the MicroNIR wavelengthscale was verified using a U.S. Pharmacopeia (USP) NIR wavelengthstandard (Lot F0G007, Catalogue number 1457844). The NIR spectrometerwas zeroed (0% reflectance) using a 2% reflective dark reference fromLabSphere, New Hampshire, USA, and a 100% baseline achieved by measuringa 99% reflective Spectralon™ ceramic reference (LabSphere). Thissequence of re-zeroing and baseline acquisition was repeated once every15 minutes during sample analysis periods. All samples were measuredeither through glass vials (capsule blend/powder) or “as is” (tablets).

Three tablets were measured for each sample brand. To minimize straylight and baseline offset differences, tablets of a same brand werescanned in exactly the same orientation. Each of the three tablets wasthen measured once, with the brand owner logo face down, that is,towards the photodetector array 38, and strength numeration face up,that is, away from the photodetector array 38. Sixty (60) scans weretaken per sample spectrum, using an integration time of 5600microseconds. Each spectrum to be analyzed was the mean of 60 scans inthe wavelength range 880 nm-1668 nm at 6 nm intervals.

For different drug comparisons, second derivative absorbance(Savitsky-Golay smoothing method, 11 data points smoothed) was achievedexporting the MicroNIR's reflectance data into the Unscrambler GENXsoftware v. 10.1. First, a reflectance was transposed into absorbance,and then a spectral second derivative transformation of this absorbancedata was performed for a wavelength range of 905 nm to 1637 nm.

To distinguish between various drug types, the second derivativeabsorbance data were imported into software for generation of PCA. Thechemometric software used was Unscrambler GENX v. 10.2 developed by CamoA/S Software, Norway. PCA was performed on the second derivativeabsorbance data from each authentic Viagra® strength (25 mg, 50 mg and100 mg Sildenafil) and the illegal generic Kamagra® 100 mg (“IG_A”),Zenegra® 100 mg (“IG_B”) and Sildigra® XL 150 mg (“IG_C”) tablets. InFIG. 8, the PCA scores plot is shown for each authentic Sildenafilstrength and illegal generic drug variants. The horizontal PC-1 andvertical PC-2 axes correspond to two latent variables termed “principalcomponents”, accounting together for 86% of the total spectralinformation contained in the calibration library or primary referencedata. One can see that Viagra tablets are clearly distinguishable fromthe illegal generic versions of the drug.

Referring to FIG. 9, the data of FIG. 8 is delineated with a 95% equalfrequency ellipse 91 drawn around the authentic Viagra tablets signsshown in diamonds, in which all strengths have been grouped together.The scores points for the Kamagra 100 mg are shown with circles; Zenegra100 mg are shown with squares; and Sildigra XL 150 mg are shown withtriangles. Any individual tablet(s), illegal generic or otherwise, thatfall outside the 95% equal frequency ellipse 91, are highly unlikely tocome from a same source. The authentic tablets (diamonds in FIG. 9) werediscriminated from the illegal generic types (circles, squares, andtriangles in FIG. 9), with Zenegra 100 mg being most similar in NIRspectra, and therefore similar in its organic composition to the Pfizerproduct. In other words, Zenegra 100 mg is likely to contain similaractive and excipient materials. Kamagra was discriminated from all otherproducts along the second (vertical) axis PC2.

Turning to FIG. 10, a two-dimensional PCA scores plot is shown fortwenty three different drugs measured using the reflective spectrometer30A of FIG. 3A, including Aleve®, Aspirin, Alorvastatin®, Cialis®,Citrizene®, Co-Codamol®, Crestor®, Dicoflex®, Duphaston®, Ezetrol®,Glucophage®, Ibuprofen®, Ibuprofen (OTC), Levitra®, Loratadine®,Malarone®, Panadol®, Panadol Extra, Ranitidine®, Sominex®, Sudafed®,Viagra, and Zirtec®. The PCA scores plot is shown in two axes: PC-1(38%), and PC-2 (22%). Referring now to FIG. 11, a three-dimensional PCAscores plot is shown for the above twenty three drugs, in three axes:PC-1 (38%), PC-2 (22%), and PC-3 (14%).

The foregoing description of one or more embodiments of the inventionhas been presented for the purposes of illustration and description. Itis not intended to be exhaustive or to limit the invention to theprecise form disclosed. Many modifications and variations are possiblein light of the above teaching. It is intended that the scope of theinvention be limited not by this detailed description, but rather by theclaims appended hereto.

What is claimed is:
 1. A medication assurance system comprising: aportable spectrometer for obtaining a light spectrum of a medication; asubject identification device for identifying a subject of medication;and a controller coupled to the portable spectrometer and the subjectidentification device, configured for identifying the medication fromthe light spectrum obtained by the portable spectrometer using achemometric analysis, and determining if the medication is to be takenby the subject.
 2. The medication assurance system of claim 1, whereinthe portable spectrometer comprises: a light source for illuminating themedication; a medication holder for holding the medication beingilluminated; a laterally variable filter for receiving light reflectedfrom, or transmitted through the medication; and a photodetector arrayoptically coupled to the laterally variable filter forwavelength-selective detection of the reflected or transmitted light,respectively.
 3. The medication assurance system of claim 2, wherein theportable spectrometer comprises a diffuse reflection spectrometer,wherein the light source is configured for directing light at themedication holder at an acute angle; the portable spectrometer furtherincluding a light collecting element disposed between the medicationholder and the laterally variable filter, for collecting light diffuselyreflected from the medication when the medication is placed into themedication holder and illuminated by the light source, and coupling thediffusely reflected light to the laterally variable filter.
 4. Themedication assurance system of claim 2, wherein the portablespectrometer comprises a transmission spectrometer, wherein the lightsource is configured for directing light through the medication holderand towards the laterally variable filter.
 5. The medication assurancesystem of claim 2, wherein the portable spectrometer is configured foroperation in a wavelength range of 800 nm to 2500 nm.
 6. The medicationassurance system of claim 1, wherein the portable spectrometer iscoupled to the controller via a wireless link.
 7. The medicationassurance system of claim 2, wherein the subject identification devicecomprises a biometric device.
 8. The medication assurance system ofclaim 1, wherein the controller is configured for providing a record ofadministering the medication to the subject.
 9. The medication assurancesystem of claim 1, further comprising a clock coupled to the controller,for determining a time of administering the medication to the subject.10. The medication assurance system of claim 9, further comprising astorage device coupled to the controller, for storing a recordcomprising an identifier of the subject; an identifier of themedication; and a timestamp including the time of administering themedication.
 11. The medication assurance system of claim 10, wherein thestorage device is disposed at a remote location, the medicationassurance system further comprising a wireless transmitter fortransmitting the record to the remote location for storage on thestorage device.
 12. The medication assurance system of claim 9, whereinthe controller includes a non-transitional memory for storing times ofrequired administering of the medication to the subject, wherein inoperation, the non-transitional memory stores information about thesubject, and information about a medication associated with the subject,the medication assurance system further comprising an alarm coupled tothe controller, for providing an audible or visible warning signal whenthe subject identified by the subject identification device is going totake medication identified by the controller to be different from theassociated medication.
 13. The medication assurance system of claim 12,wherein the controller is configured to cause the alarm to provide anaudible or visible reminder of one of the times for the subject to takethe associated medication.
 14. The medication assurance system of claim12, further comprising an automatic medication dispenser mechanicallycoupled to the medication holder, for automatically dispensing themedication associated with the subject at the times of requiredadministering of the medication to the subject.
 15. The medicationassurance system of claim 12, further comprising a blocking mechanismcoupled to the controller, for preventing the subject from taking themedication identified by the controller to be different from theassociated medication.
 16. A medication assurance system comprising: aportable spectrometer for obtaining a light spectrum of a medication; asubject identification device for identifying a subject of medication;and a controller coupled to the portable spectrometer and the subjectidentification device, configured for identifying the medication fromthe light spectrum obtained by the portable spectrometer using achemometric analysis, and providing a record of administering theidentified medication to the identified subject.
 17. A method forpreventing a subject from taking an incorrect medication, the methodcomprising: (a) using a portable spectrometer to obtain a light spectrumof a medication; (b) identifying the medication by performing achemometric analysis of the light spectrum obtained in step (a); (c)identifying the subject using a biometric device; (d) for the subjectidentified in step (c), determining an associated medication based on apre-existing record; (e) determining that the medication identified instep (b) is not the associated medication determined in step (d); and(f) upon completion of step (e), generating an alarm for informing thesubject that the medication is an incorrect medication.
 18. The methodof claim 17, wherein step (a) includes using a portable diffusereflection spectrometer having a laterally variable filter opticallycoupled to a photodetector array, wherein the light spectrum comprises adiffuse reflection spectrum of the medication.
 19. A method for trackingadministering of a medication to a subject, the method comprising: (a)using a portable spectrometer to obtain a light spectrum of amedication; (b) identifying the medication by performing a chemometricanalysis of the light spectrum obtained in step (a); (c) identifying thesubject using a biometric device; (d1) creating a record including: atimestamp; the medication identified in step (b); and the subjectidentified in step (c).
 20. The method of claim 19, wherein step (a)includes using a portable diffuse reflection spectrometer having alaterally variable filter optically coupled to a photodetector array,wherein the light spectrum comprises a diffuse reflection spectrum ofthe medication.